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. 2025 Jul 21;45(5):441–453. doi: 10.1097/JCP.0000000000002047

TABLE 3.

Summary of Treatment-Emergent Adverse Events (Safety Analysis Set).

Participants With AE RE104 5 mg (N=6) n (%) E RE104 10 mg (N=6) n (%) E RE104 20 mg (N=6) n (%) E RE104 30 mg (N=9) n (%) E RE104 35 mg (N=6) n (%) E RE104 40 mg (N=3) n (%) E Pooled Placebo (N=12) n (%) E
≥1 TEAE 2 (33.3) 3 2 (33.3) 4 2 (33.3) 5 8 (88.9) 30 5 (83.3) 31 3 (100) 16 4 (33.3) 5
Nausea 1 (16.7) 1 2 (33.3) 2 0 3 (33.3) 3 2 (33.3) 2 2 (66.7) 2 0
Sinus tachycardia 0 0 0 4 (44.4) 8 3 (50.0) 7 2 (66.7) 4 0
Restlessness 0 0 0 3 (33.3) 3 3 (50.0) 3 1 (33.3) 1 0
Headache 0 1 (16.7) 1 0 1 (11.1) 2 4 (66.7) 4 0 0
Agitation 0 0 0 0 2 (33.3) 3 2 (66.7) 3 0
Muscle twitching 0 0 0 3 (33.3) 4 0 0 0
Diarrhea 0 0 1 (16.7) 1 0 2 (33.3) 2 0 0
Hyperhidrosis 0 0 1 (16.7) 1 0 1 (16.7) 1 1 (33.3) 1 0
Abdominal pain 0 0 0 2 (22.2) 2 0 0 0
Vomiting 1 (16.7) 1 0 0 0 0 1 (33.3) 1 0
Fatigue 0 0 0 2 (22.2) 2 0 0 0
Thirst 0 0 0 0 2 (33.3) 2 0 0
Tremor 0 0 0 1 (11.1) 1 0 1 (33.3) 1 0
Feeling hot 0 0 1 (16.7) 1 0 0 0 1 (8.3) 1
Myalgia 0 0 0 0 1 (16.7) 2 0 0
Dysphoria 0 0 0 0 1 (16.7) 2 0 0
Gastroenteritis 0 0 0 0 0 0 1 (8.3) 1
Chest discomfort 0 1 (16.7) 1 0 0 0 0 0
Injection site bruising 0 0 0 1 (11.1) 1 0 0 0
Folliculitis 1 (16.7) 1 0 0 0 0 0 0
Musculoskeletal injury 0 0 0 1 (11.1) 1 0 0 1 (8.3) 2
Palpitations 0 0 1 (16.7) 1 0 0 0 1 (8.3) 1
Ageusia 0 0 0 0 1 (16.7) 1 0 0
Syncope 0 0 0 1 (11.1) 1 0 0 0
Tension headache 0 0 0 1 (11.1) 1 0 0 0
Anxiety 0 0 1 (16.7) 1 0 0 0 0
Fear 0 0 0 0 0 1 (33.3) 1 0
Hallucination 0 0 0 0 1 (16.7) 1 0 0
Irritability 0 0 0 0 0 1 (33.3) 1 0
Hypotension 0 0 0 0 1 (16.7) 1 0 0